NOVEL COLLAGEN-BASED PERIPHERAL ENDOPROSTHESIS

尽管经皮腔内血管成形术（PTA）和血管内支架置入术被广泛接受用于治疗周围动脉粥样硬化病变患者，但这些技术存在一些缺陷，限制了它们的整体临床成功。再狭窄的高发生率仍然是PTA和血管内支架手术的主要并发症。本研究的总体目标是设计、开发并在体内测试一种新型胶原基内假体，以降低pta后再狭窄的发生率。在初步研究中，采用兔主动脉模型对内假体原型进行了急性和慢性体内试验。结果表明，该假体原型具有良好的血液相容性，炎症反应最小。在第一阶段，我们计划改进内假体原型的设计和制造，并在犬髂动脉模型中进行可行性测试。在二期研究中，我们将扩大研究范围，包括硬化的犬和猪动脉，并评估内假体在降低再狭窄率方面的长期有效性。拟议的商业应用：据估计，仅1995年美国就有超过15万例经皮腔内血管成形术（PTA）用于治疗周围动脉粥样硬化病变患者。晚期再狭窄的发生通常会导致再干预，导致患者护理总成本的显著增加。如果提出的内假体装置功能良好，再狭窄率降低5%可以转化为每年节省超过1亿美元的相关医疗费用。

Despite the wide acceptance of percutaneous transluminal angioplasty (PTA) ana intravascular stenting for treating patients with peripheral atherosclerotic lesions, these techniques suffer some drawbacks which limit their overall clinical success. A high rate of restenosis remains the major complication of PTA and intravascular stenting procedures. The overall goal of this research is to design, develop and test in vivo a novel collagen-based endoprosthesis for reducing the rate of post-PTA restenosis. In the preliminary studies, acute and chronic in vivo testing of an endoprosthesis prototype was conducted using a rabbit aorta model. The results showed that the endoprosthesis prototype had excellent hemocompatibility and induced minimal inflammatory response. During the phase I, we plan to improve the design and fabrication of the endoprosthesis prototype and conduct a feasibility testing in a canine iliac artery model. In the phase II, we will extend the study to include sclerotic canine and porcine arteries and evaluate the long term effectiveness of the endoprosthesis in reducing the rate of restenosis. PROPOSED COMMERCIAL APPLICATIONS: There were estimated to be more than 150,000 percutaneous transluminal angioplasty (PTA) procedures performed to treat patients with peripheral atherosclerotic lesions in the U.S. in 1995 alone. The occurrence of late restenosis typically lead to reinterventions that result in a significant increase of the total cost of patient care. If the proposed endoprosthesis device functions well, a 5% reduction of the restenosis rate can be translated into a savings of more than $100 million dollars a year in the associated healthcare cost.